Recruiting
Early Phase 1

SGLT2 Inhibitors, Ketones

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05057806

Conditions

Type2 Diabetes

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 25 MG

Placebo

Study Details

Brief summary:

The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.

Conditions

Type2 Diabetes

Heart Failure With Preserved Ejection Fraction

Study ID

NCT05057806

Start date

Jan 13, 2021

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) <50%
  • Age 18-80 years
  • BMI 23-38 kg/m2
  • Glycated hemoglobin (HbA1c) 5.5-10%
  • Blood Pressure (BP) ≤ 145/85 mmHg
  • Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
  • Stable dose of guideline-directed medications for heart failure and Diabetes
  • Stable body weight (±4 pounds) over the last 3 months
  • Does not suffer from severe claustrophobia
  • No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Exclusion Criteria:

  • Subjects treated with an SGLT2 inhibitor, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or pioglitazone
  • Pregnancy, lactation or plans to become pregnant
  • Allergy/sensitivity to study drugs or their ingredients
  • Cancer
  • Current drug or alcohol use or dependence
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Empagliflozin Group

Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months

placebo comparator: Placebo group

Subjects will be randomized to receive the empagliflozin placebo for 3 months

Interventions

Empagliflozin 25 MG

Empagliflozin 25MG will be administered orally once per day for 3 months

Placebo

The placebo will be administered orally once per day for 3 months

Primary outcome measure

  • Change in Phosphocreatine [ Time Frame: Baseline to 3 months ]
  • Change in Adenosine Triphosphate (ATP) [ Time Frame: Baseline to 3 months ]
  • Change in Inorganic Phosphate [ Time Frame: Baseline to 3 months ]
  • Change in Phosphodiester [ Time Frame: Baseline to 3 months ]
  • ATPmax production [ Time Frame: Baseline to 3 months ]

Central Contacts and Locations

Central contacts

Carolina Solis-Herrera, MD

210-567-4900solisherrera@uthscsa.edu

Francisca M Acosta, PhD

210-450-8677acostafm@uthscsa.edu

Locations

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Carolina Solis-Herrera, MD

210-567-4800solisherrera@uthscsa.edu

Francisca M Acosta, PhD

210-450-8677acostafm@uthscsa.edu

Principal Investigator:

Carolina Solis-Herrera, MD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

Keywords

  • Ketones
  • Cardiovascular benefit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-04-06.